Cleared Traditional

K924105 - SNARE FLEXIBLE

K924105 is the FDA 510(k) clearance for SNARE FLEXIBLE by United States Endoscopy Group, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FDI) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K924105 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Nov 1992
Decision
103d
Days
Class 2
Risk

K924105 is an FDA 510(k) clearance for the SNARE FLEXIBLE. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on November 24, 1992 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K924105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1992
Decision Date November 24, 1992
Days to Decision 103 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 130d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDI Snare, Flexible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FDI Snare, Flexible

All 36
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K924105.
PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES
K941750 · Boston Scientific Corp · Nov 1994
ENDOSNARE
K923031 · Cook Urological, Inc. · Jun 1993
SPHINCTEROTOME
K930022 · Boston Scientific Corp · Apr 1993
LAPAROSCOPIC SNARE
K911482 · United States Endoscopy Group, Inc. · Apr 1991
DOBBHOFF(R) POLYPECTOMY SNARE
K901322 · Biosearch Medical Products, Inc. · Jun 1990
DAVOL POLYPECTOMY SNARE
K845016 · C.R. Bard, Inc. · Jan 1985